MenopauseNCT07044284
The Effects of Fractal Mindfulness Virtual Reality on Menopause Symptoms
A study testing Fractal mindfulness recombination in people with Menopause, run by London Metropolitan University at 1 site in United Kingdom.
Trial summary
The study aimed to establish the effectiveness of an immersive mindfulness virtual reality intervention using fractal software for women experiencing menopausal symptoms. It was hypothesised that post immersive virtual reality fractal mindfulness intervention would result in higher levels of sexual function, wellbeing… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Fractal mindfulness recombination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Feb 2025to 26 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have perceived peri or menopausal symptoms
- Must have normal or corrected to normal hearing and vision
- Must be 18 years or older
- Must have used virtual reality before with no side effects
- Must have a pulse rate of 60 to 80 beats per minute
- Must NOT experience seizures
- Must NOT have coordination difficulties
Who cannot join
- Do not have peri or menopausal symptoms
- Have coordination difficulties
- Report having claustrophobia
- Pulse rate higher than 80 at rest
- Have sensitivities to flashing lights
- Are prone to migraine
- Have seizures Are younger than 18 years old
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Social Science and Professions
London, N7 8DB
About this study
Official title: A Pilot Study Looking at the Use of Virtual Reality Mindfulness Fractals in Addressing Menopause Symptoms, Sexual Function, Cognitive Mindfulness and Well-being
The study aimed to establish the effectiveness of an immersive mindfulness virtual reality intervention using fractal software for women experiencing menopausal symptoms.
It was hypothesised that post immersive virtual reality fractal mindfulness intervention would result in higher levels of sexual function, wellbeing and cognitive mindfulness with lower levels of menopause symptoms. It was further hypothesised that in physiological responses, the pulse rate would be lower post intervention per session and an overall reduction in pulse rate post intervention. An electroencephalogram will be used to monitor alpha and beta ratios.
Read the detailed description
Menopause is both a biological and psychological milestone that signifies the end of a woman's reproductive capacity and typically occurs between the ages of 45 and 55. A multitude of physiological, emotional, cognitive, and sexual symptoms often accompany this transition.
Putting aside the standard biopsychosocial interventions to one side, an alternative approach gaining momentum, associated with supporting meditation and mindfulness practices, is the use of fractals. Fractals exhibit varying levels of repetition with a rate of pattern shrinkage between repetitions, denoted by the D value where research has shown that fractals can reduce stress levels by increasing alpha brain wave in the frontal area of the brain. Fractal mindfulness utilises self-similar, repetitive patterns found in fractals to promote relaxation and offers insights into our perception of reality. With fractal mindfulness, the focus is on the present moment. This idea has been linked to spirituality because it explains humans' universal and innate subconscious understanding of the world. Increased levels of meditation are often associated with higher alpha and theta brain oscillations. Furthermore, sound can support the meditative state through beat frequencies, which can be observed through physiological measures such as changes in heart rate, increased relaxation, and a hypnotic state. Therefore, when fractals and music are combined, they may arguably create a more powerful response that fosters meditative awareness.
Artificial fractals may include computer-generated fractals, which are becoming increasingly widespread due to the increased use of digital technology, as recursive algorithms are used to generate them. However, living conditions do not always permit a complete connection with fractals in nature, and perhaps the increasing use of technology and virtual reality could serve as a helpful alternative. Fractals have become more accessible and scalable through digital platforms, enabling their integration into mainstream healthcare.
Despite the growing interest in fractals and digital health, few studies have explored the intersection of these two areas with menopause. Based on the literature review, this exploratory study examined the impact of a novel, immersive fractal mindfulness intervention on menopause-related symptoms, as well as sexual function, cognitive mindfulness, and overall well-being. This study employed a mixed methods approach, evaluating symptom change both quantitatively through standardised questionnaires and qualitatively through open-ended survey responses. Heart rate and an electroencephalogram further placed the outcomes into context, particularly when examining alpha and beta ratios.
All participants received the same intervention and were assessed at three time points: baseline week 0, post intervention week 4, and follow up week 8 in a waitlist randomised controlled study, which included active and delayed groups consisting of nine participants in each group. This ensured that every participant received the intervention. Feedback was solicited through five open ended questions to gauge the participants' perceptions of their experiences with the intervention. Pulse rate was recorded both before and after the session, and a basic electroencephalogram was employed to determine any increase in alpha waves in the occipital region, as guided by research. The emphasis was on the brain processing visual information and maintaining attention, particularly when the eyes are open and receiving input.
The design was chosen for its suitability in small-sample and exploratory studies, permitting the study of individual changes over time. The four-week intervention period and follow up assessment were chosen to capture both immediate and sustained effects of fractal virtual reality. A randomised waitlist-controlled study is often employed in conjunction with therapeutic interventions. The delayed group provides an untreated comparison for the active group.
- Conditions
- Menopause
- Being tested
- Fractal mindfulness recombination
- Keywords
- fractal mindfulness, wellbeing, Cognitive mindfulness, Sexual functioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractal mindfulness recombinationDevice
Immersive virtual reality using fractal mindfulness software
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Fractal Mindfulness Virtual Reality Receives: Device: Fractal mindfulness recombination |
| Delayed group | Active comparator | Fractal Mindfulness Virtual Reality Receives: Device: Fractal mindfulness recombination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause symptoms
This 17 item questionnaire consists of a 4 option (0 not at all, 4 a lot) Likert scale that evaluates menopause symptoms. Example symptoms include difficulty concentrating, loss of interest in sex, pain during sex, and vaginal dryness. Areas are divided into vasomotor symptoms, emotional symptoms, local and sexual symptoms, as well as various physiological symptoms. The Cronbach's alpha is .752. Higher scores indicate higher symptoms of menopause.
Measured: 0, 4 and 8 weeks
Secondary outcomes (3)
Cognitive mindfulness
This is a 10 item questionnaire with 5 response categories (1 never or rarely true through 5 very often always true). Cronbach alpha ranges between 0.69 and 0.76. Subscale scoring is divided into 5 areas, including observing, describing, acting with awareness, non-judging, and non-reactivity. Higher scores reflect higher levels of mindfulness endorsement.
Measured: 0, 4 and 8 weeks
Female Sexual Function Index
This is a 19 item questionnaire on sexual function, including sexual desire, orgasm, lubrication, sexual satisfaction and pain. It has five response categories. Scores include severe 2-7.2, moderate 7.3-14.4, mild to moderate 14.5-21.6, mild 21.7- 28.1 cut-off value, and no female sexual dysfunction 28.2 -36.The lower the score, the higher the level of sexual dysfunction.
Measured: 0, 4 and 8 weeks
The Short Warwick Edinburgh Mental Wellbeing Scale
A 7 item questionnaire with 5 response categories looking at functioning and feeling aspects of wellbeing. The response categories include 1, none of the time, to 5, all of the time. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing.The Cronbach alpha is equal to or greater than 0.70.
Measured: 0, 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start2 Feb 2025
- Primary completion30 May 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An active and a delayed group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Banbury, London Metropolitan University
- Investigators
- Samantha Banbury, Principal investigator, London Met Uni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044284
- Sponsor's protocol ID
- ALondonUni
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma J, Zhao D, Xu N, Yang J. The effectiveness of immersive virtual reality (VR) based mindfulness training on improvement mental-health in adults: A narrative systematic review. Explore (NY). 2023 May-Jun;19(3):310-318. doi: 10.1016/j.explore.2022.08.001. Epub 2022 Aug 5.
PubMed 36002363Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
PubMed 10782451Feldman, G., Hayes, A., Kumar, S., Greeson, J., & Laurenceau, J. P. (2007). Mindfulness and emotion regulation: The development and initial validation of the Cognitive and Affective Mindfulness ScaleRevised (CAMS-R). Journal of Psychopathology and Behavioral Assessment, 29(3), 177-190
Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
PubMed 18042300Prause N, Staley C, Roberts V. Frontal alpha asymmetry and sexually motivated states. Psychophysiology. 2014 Mar;51(3):226-35. doi: 10.1111/psyp.12173. Epub 2014 Jan 27.
PubMed 24460762Ciaurriz Larraz AM, Villena Moya A, Chiclana Actis C. Mindfulness-based intervention and sexuality: a systematic review. Trends Psychiatry Psychother. 2024;46:e20210459. doi: 10.47626/2237-6089-2021-0459. Epub 2023 Feb 20.
PubMed 36803998Amin SM, El-Gazar HE, Zoromba MA, El-Sayed MM, Awad AGE, Atta MHR. Mindfulness for Menopausal Women: Enhancing Quality of Life and Psychological Well-Being Through a Randomized Controlled Intervention. J Nurs Scholarsh. 2025 Jul;57(4):563-575. doi: 10.1111/jnu.70003. Epub 2025 Feb 24.
PubMed 39992004Bies AJ, Blanc-Goldhammer DR, Boydston CR, Taylor RP, Sereno ME. Aesthetic Responses to Exact Fractals Driven by Physical Complexity. Front Hum Neurosci. 2016 May 20;10:210. doi: 10.3389/fnhum.2016.00210. eCollection 2016.
PubMed 27242475
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Looking at the Use of Virtual Reality Mindfulness Fractals in Addressing Menopause Symptoms, Sexual Function, Cognitive Mindfulness and Well-being
- ClinicalTrials.gov ID
- NCT07044284
- Acronym / sponsor ID
- ALondonUni
- Conditions
- Menopause
- Keywords
- fractal mindfulness, wellbeing, Cognitive mindfulness, Sexual functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- London Metropolitan UniversityUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to establish the effectiveness of an immersive mindfulness virtual reality intervention using fractal software for women experiencing menopausal symptoms.
It was hypothesised that post immersive virtual reality fractal mindfulness intervention would result in higher levels of sexual function, wellbeing and cognitive mindfulness with lower levels of menopause symptoms. It was further hypothesised that in physiological responses, the pulse rate would be lower post intervention per session and an overall reduction in pulse rate post intervention. An electroencephalogram will be used to monitor alpha and beta ratios.
Detailed description
Menopause is both a biological and psychological milestone that signifies the end of a woman's reproductive capacity and typically occurs between the ages of 45 and 55. A multitude of physiological, emotional, cognitive, and sexual symptoms often accompany this transition.
Putting aside the standard biopsychosocial interventions to one side, an alternative approach gaining momentum, associated with supporting meditation and mindfulness practices, is the use of fractals. Fractals exhibit varying levels of repetition with a rate of pattern shrinkage between repetitions, denoted by the D value where research has shown that fractals can reduce stress levels by increasing alpha brain wave in the frontal area of the brain. Fractal mindfulness utilises self-similar, repetitive patterns found in fractals to promote relaxation and offers insights into our perception of reality. With fractal mindfulness, the focus is on the present moment. This idea has been linked to spirituality because it explains humans' universal and innate subconscious understanding of the world. Increased levels of meditation are often associated with higher alpha and theta brain oscillations. Furthermore, sound can support the meditative state through beat frequencies, which can be observed through physiological measures such as changes in heart rate, increased relaxation, and a hypnotic state. Therefore, when fractals and music are combined, they may arguably create a more powerful response that fosters meditative awareness.
Artificial fractals may include computer-generated fractals, which are becoming increasingly widespread due to the increased use of digital technology, as recursive algorithms are used to generate them. However, living conditions do not always permit a complete connection with fractals in nature, and perhaps the increasing use of technology and virtual reality could serve as a helpful alternative. Fractals have become more accessible and scalable through digital platforms, enabling their integration into mainstream healthcare.
Despite the growing interest in fractals and digital health, few studies have explored the intersection of these two areas with menopause. Based on the literature review, this exploratory study examined the impact of a novel, immersive fractal mindfulness intervention on menopause-related symptoms, as well as sexual function, cognitive mindfulness, and overall well-being. This study employed a mixed methods approach, evaluating symptom change both quantitatively through standardised questionnaires and qualitatively through open-ended survey responses. Heart rate and an electroencephalogram further placed the outcomes into context, particularly when examining alpha and beta ratios.
All participants received the same intervention and were assessed at three time points: baseline week 0, post intervention week 4, and follow up week 8 in a waitlist randomised controlled study, which included active and delayed groups consisting of nine participants in each group. This ensured that every participant received the intervention. Feedback was solicited through five open ended questions to gauge the participants' perceptions of their experiences with the intervention. Pulse rate was recorded both before and after the session, and a basic electroencephalogram was employed to determine any increase in alpha waves in the occipital region, as guided by research. The emphasis was on the brain processing visual information and maintaining attention, particularly when the eyes are open and receiving input.
The design was chosen for its suitability in small-sample and exploratory studies, permitting the study of individual changes over time. The four-week intervention period and follow up assessment were chosen to capture both immediate and sustained effects of fractal virtual reality. A randomised waitlist-controlled study is often employed in conjunction with therapeutic interventions. The delayed group provides an untreated comparison for the active group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An active and a delayed group
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Device: Fractal mindfulness recombinationFractal Mindfulness Virtual Reality |
| Delayed group | Active comparator | Device: Fractal mindfulness recombinationFractal Mindfulness Virtual Reality |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must have perceived peri or menopausal symptoms
- Must have normal or corrected to normal hearing and vision
- Must be 18 years or older
- Must have used virtual reality before with no side effects
- Must have a pulse rate of 60 to 80 beats per minute
Key exclusion criteria (7 listed)
- Do not have peri or menopausal symptoms
- Have coordination difficulties
- Report having claustrophobia
- Pulse rate higher than 80 at rest
- Have sensitivities to flashing lights
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractal mindfulness recombinationImmersive virtual reality using fractal mindfulness software | Device | Active group, Delayed group |
Primary outcome
Menopause symptoms
Time frame: 0, 4 and 8 weeks
This 17 item questionnaire consists of a 4 option (0 not at all, 4 a lot) Likert scale that evaluates menopause symptoms. Example symptoms include difficulty concentrating, loss of interest in sex, pain during sex, and vaginal dryness. Areas are divided into vasomotor symptoms, emotional symptoms, local and sexual symptoms, as well as various physiological symptoms. The Cronbach's alpha is .752. Higher scores indicate higher symptoms of menopause.
3 secondary outcomes
Cognitive mindfulness
Time frame: 0, 4 and 8 weeks
Female Sexual Function Index
Time frame: 0, 4 and 8 weeks
The Short Warwick Edinburgh Mental Wellbeing Scale
Time frame: 0, 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Results publication: PubMed 36002363Ma J, Zhao D, Xu N, Yang J. The effectiveness of immersive virtual reality (VR) based mindfulness training on improvement mental-health in adults: A narrative systematic review. Explore (NY). 2023 May-Jun;19(3):310-318. doi: 10.1016/j.explore.2022.08.001. Epub 2022 Aug 5.
- Results publication: PubMed 10782451Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
- Results publicationFeldman, G., Hayes, A., Kumar, S., Greeson, J., & Laurenceau, J. P. (2007). Mindfulness and emotion regulation: The development and initial validation of the Cognitive and Affective Mindfulness ScaleRevised (CAMS-R). Journal of Psychopathology and Behavioral Assessment, 29(3), 177-190
- Results publication: PubMed 18042300Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
- Results publication: PubMed 24460762Prause N, Staley C, Roberts V. Frontal alpha asymmetry and sexually motivated states. Psychophysiology. 2014 Mar;51(3):226-35. doi: 10.1111/psyp.12173. Epub 2014 Jan 27.
- Results publication: PubMed 36803998Ciaurriz Larraz AM, Villena Moya A, Chiclana Actis C. Mindfulness-based intervention and sexuality: a systematic review. Trends Psychiatry Psychother. 2024;46:e20210459. doi: 10.47626/2237-6089-2021-0459. Epub 2023 Feb 20.
- Results publication: PubMed 39992004Amin SM, El-Gazar HE, Zoromba MA, El-Sayed MM, Awad AGE, Atta MHR. Mindfulness for Menopausal Women: Enhancing Quality of Life and Psychological Well-Being Through a Randomized Controlled Intervention. J Nurs Scholarsh. 2025 Jul;57(4):563-575. doi: 10.1111/jnu.70003. Epub 2025 Feb 24.
- Results publication: PubMed 27242475Bies AJ, Blanc-Goldhammer DR, Boydston CR, Taylor RP, Sereno ME. Aesthetic Responses to Exact Fractals Driven by Physical Complexity. Front Hum Neurosci. 2016 May 20;10:210. doi: 10.3389/fnhum.2016.00210. eCollection 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Banbury principal investigator
London Met Uni
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractal mindfulness recombination in people with Menopause, run by London Metropolitan University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause symptoms (time frame: 0, 4 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07044284, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.